Class II — Reichert, Inc.
| Recalling firm | REICHERT INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. |
| Product | Phoroptor VRx Digital Refraction System Model Numbers: 16241 |
| Quantity | 122 units |
| Distribution | Domestic: Nationwide Distribution. International: Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and United Kingdom. |
| Initiated | 2025-02-28 |
| Classified | 2025-03-31 |
| Recall number | Z-1500-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Reichert, Inc. (Z-1500-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96266/
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